Prostate-Rectal Separation With PEG Hydrogel and Its Effect on Decreasing Rectal Dose
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02212548|
Recruitment Status : Completed
First Posted : August 8, 2014
Last Update Posted : September 11, 2019
|Condition or disease||Intervention/treatment||Phase|
|Cancer of the Prostate||Device: PEG Hydrogel (SpaceOAR)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prostate-Rectal Separation With PEG Hydrogel and Its Effect on Decreasing Rectal Dose|
|Actual Study Start Date :||March 2012|
|Actual Primary Completion Date :||December 2013|
|Actual Study Completion Date :||December 2016|
The patient will be in the dorsal lithotomy position and prepared and draped. A transrectal ultrasound (TRUS) will be used for alignment of the needle and to ensure safe delivery. The hydrogel precursor and accelerator solutions will be mixed and connected to the Y connector that has been flushed with saline and to a syringe holder that ensures both syringe barrels are injected at the same time. After aspirating to ensure the tip of the needle is not intravascular, the perirectal space will be adequately dissected from the apex to midgland by injecting saline into the space between denonvilliers fascia and the anterior rectal space under TRUS guidance. Maintaining the needle position and angulation, the saline syringe is disconnected and the hydrogel system connected. After aspirating to ensure the needle tip is not in a blood vessel and under TRUS guidance, the 'PEG Hydrogel (SpaceOAR) is injected in a smooth, continuous technique.
Device: PEG Hydrogel (SpaceOAR)
A single injection of PEG hydrogel (SpaceOAR) through the perineum under transrectal ultrasound guidance while under general anaesthetic.
- % volume of rectum receiving 40Gy, 65Gy, 70Gy, 75Gy and 80Gy [ Time Frame: CT scans taken 1-2 weeks apart (Pre and post Hydrogel insertion) ]Estimated % volume of rectum as measured on CT dosimetry based on CT scans ore and post insertion of hydrogel taken 1-2 weeks apart (% volume of rectum receiving 40Gy, 65Gy, 70Gy, 75Gy and 80Gy).
- Evaluation of serious adverse events or complications secondary to PEG hydrogel insertion. [ Time Frame: Post-Hydrogel Insertion then 2nd weekly during radiation therapy up to 9 weeks and at a 3 month follow-up. ]Physcian reported toxicity using CTC
- Gastrointestinal toxicity [ Time Frame: Second weekly evaluation during radiation therapy up to 9 weeks and at 3 mths, 9 mths, 15 mths, 21 mths, 27mths and 36mths post treatment. ]Patients will be physician scored using the CTC and patient scored using the EPIC QOL questionaire
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02212548
|Australia, New South Wales|
|Northern Sydney Cancer Centre, Royal North Shore Hospital|
|St. Leonards, New South Wales, Australia, 2065|
|Principal Investigator:||Thomas Eade, MD||Royal North Shore Hospital|